(93 days)
ILJ
Not Found
No
The summary describes a hydro-bath system with updated temperature sensors and indicators, but no mention of AI or ML capabilities.
No
The device is used for bathing and hygiene to prevent the spread of disease, which falls under general wellness and cleaning, not therapeutic treatment or diagnosis of a specific medical condition.
No
The intended use of the device is for bathing and hygiene to prevent the spread of disease, not for diagnosing medical conditions.
No
The device description explicitly mentions "technology and components" and "temperature sensor and temperature read-out indicators," indicating it is a hardware system, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the bathing and hygiene of residents/patients. This is a physical care activity, not a diagnostic test performed on samples taken from the body.
- Indications for Use: The indications relate to maintaining a clean environment to prevent disease spread, which is a public health and hygiene measure, not a diagnostic process.
- Device Description: The description focuses on the technology and components of a hydro-bath, which is a physical bathing system.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The intended use of this device is the bathing and hygiene of residents/patients in hospitals, nursing homes, or assisted living facilities. The indications for use are the necessity and advisability of a clean and healthy environment in these facilities to prevent the spread of disease.
Product codes
ILJ
Device Description
The safety and usefulness of the VÄNNA Bathing System is based on a long history of use of hydro-baths with similar characteristics. As referred to previously the VÄNNA Bathing System uses similar technology and components as other devises already on the market. Technological updates have been used in the VÄNNA Bathing System in the temperature sensor and temperature read-out indicators but these differences enhance the reliability of this devise. Also the intended use of these devices is very similar.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals, nursing homes, or assisted living facilities.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Century Bathing System, Sanitas Bathing System, Smart Tub
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5100 Immersion hydrobath.
(a)
Identification. An immersion hydrobath is a device intended for medical purposes that consists of water agitators and that may include a tub to be filled with water. The water temperature may be measured by a gauge. It is used in hydrotherapy to relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for removal of contaminated tissue.(b)
Classification. Class II (special controls). The device, when it is a hydromassage bath or a powered sitz bath, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
0
FEB 1 6 2000
Image /page/0/Picture/1 description: The image shows a logo for VANCARE inc. The logo consists of a large, stylized letter V on the left, with the text "VANCARE inc." to the right of the V. Below the text is the location "Aurora, NI 68818 1103".
510k Summary
The safety and usefulness of the VÄNNA Bathing System is based on a long history of use of hydro-baths with similar characteristics. As referred to previously the VÄNNA Bathing System uses similar technology and components as other devises already on the market. Technological updates have been used in the VÄNNA Bathing System in the temperature sensor and temperature read-out indicators but these differences enhance the reliability of this devise. Also the intended use of these devices is very similar.
In summary and conclusion the VÄNNA Bathing System is "substantially equivalent" to the Century Bathing System, Sanitas Bathing System and the Smart Tub as to pre-market notification purposes. We respectfully request the FDA's concurrence with this conclusion.
This pre-market notification and its enclosures are being submitted in triplicate. Please do not hesitate to contact us if you have any questions or need additional information.
Sincerely,
Kuklats
James A. Vanderheiden President
JVA/gd Enclosures
(402) 694-4525
FAX (402) 694-3994
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 6 2000
Mr. James A. Vanderheiden President VANCARE, Inc. 1515 1st Street Aurora, Nebraska 68818
Re: K993872 Trade Name: VANNA Bathing System Regulatory Class: II Product Code: ILJ Dated: January 28, 2000 Received: January 31, 2000
Dear Mr. Vanderheiden
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
2
Page 2 – Mr. James A. Vanderheiden
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
Mark A Mulhausen
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) NUMBER (IF KNOWN) : K993872 DEVICE NAME : VANNA Bathing System INDICATIONS FOR USE:
The intended use of this device is the bathing and hygiene of residents/patients in hospitals, nursing homes, or assisted living facilities. The indications for use are the necessity and advisability of a clean and healthy environment in these facilities to prevent the spread of disease.
Mark A. Mulhausen
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K993872
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use
(Optional Format 1-2.